A fantastic oppertunity is now available for science graduates.
Responsibilities:
1 Clinical Trial Safety Data Processing
2 Post-Marketing Safety Data Processing
3 Regulatory Safety Data Processing
4 Clinical Event Validation and Adjudication Processing
5 Participate in project, team and group meetings
6 Comply with company Core Operating Procedures (COPs) and participate
in the review of existing COPs
7 Identify and record quality problems and bring them to the attention of a
senior team member
8 Interact with Physician and / or Project Medical Officer as appropriate
9 Generate status reports as required.
10 Project Start-up, with supervision
11 Draft project instructions / guidelines for project and amend when
appropriate
12 Attend / present at investigator / CRA meetings.
13 Liaise with PM and / or members of project team (CRAs, Data
Management).
14 Know, understand and comply with relevant ICH GCP
15 QC of safety data
16 Ensure alert letters are submitted on time.
17 Perform other duties as directed by management
Minimum education and experience
A degree or equivalent in scientific or health care discipline.
Knowledge of medical terminology preferred, but not mandatory.
Excellent verbal and written communication skills.
Fluency in English; an additional European language is an asset.
Good interpersonal and organizational skills.
Positive forward thinking individuals
Demonstrate keen eye for detail
Demonstrate an ability to work in a pressurised team office environment
Computer literacy required |
